Paul Tassin  |  July 29, 2016

Category: Legal News

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Essure ProblemsA group of 91 women is suing the makers of the Essure permanent birth control system, claiming that Essure causes permanent injuries.

The plaintiffs say they brought all their claims together as a single lawsuit because they raise similar questions of law and fact.

All 91 plaintiffs allege they had Essure implanted, that they relied on the same representations by Bayer, that Bayer failed to warn them that Essure causes permanent injuries, and that they suffered such injuries after implantation of Essure.

According to this Essure lawsuit, Essure is a method of permanent birth control that prevents fertilization by causing permanent occlusion of the fallopian tubes.

It consists of a pair of metal coils that are inserted in the patient’s fallopian tubes. Over time, the coils stimulate growth of new tissue that eventually blocks the tubes, preventing fertilization.

Essure was designed to be implanted in a “quick and easy” outpatient procedure, plaintiffs say. Patients are instructed to undergo follow-up testing three months after implantation to confirm the implants are working properly.

Plaintiffs argue that FDA approval of Essure has been invalidated due to Bayer’s failure to live up to the conditions of that approval. Original FDA approval for Essure was secured by Conceptus, the company that developed it. Bayer purchased Conceptus in 2013.

Plaintiffs say that the FDA’s approval for Essure was conditioned on its manufacturer’s satisfaction of certain reporting requirements, including reporting known hazards to the FDA, and on the manufacturer’s continued compliance with federal laws governing marketing and distribution.

According to several documented FDA findings, the plaintiffs claim, Bayer has failed to satisfy these conditions.

They say Bayer has been cited by the FDA and the Department of Health for using nonconforming materials in the manufacture of Essure, for manufacturing Essure at an unlicensed facility, and for manufacturing Essure for three years without a license to do so.

They also say the FDA found, among other alleged failures, that Bayer failed to report instances in which Essure coils fractured, migrated out of the fallopian tubes or perforated the patient’s bowels or other tissue. Plaintiffs claim the company actively concealed evidence suggesting Essure causes permanent injuries.

Bayer allegedly disclosed only 22 cases of bowel perforation, even though it had evidence of 144 such cases.

Essure Causes Permanent Injuries Due to Inadequate Training, Say Plaintiffs

The plaintiffs also take issue with how Bayer trained physicians to implant Essure. Bayer provided physicians with hysteroscopic equipment necessary to implant Essure. Plaintiffs say this equipment was not covered under Essure’s conditional FDA approval.

They argue that Bayer indiscriminately handed this equipment out to physicians who were not qualified to use it. In exchange for the equipment, Bayer required these physicians to purchase two Essure kits per month.

Plaintiffs say this was an “unreasonably dangerous and negligent distribution plan” that served only business purposes while disregarding the patients’ safety.

Plaintiffs have asked the court for special management of the case due to its complexity. Paperwork filed with the Essure lawsuit indicates it may be suitable for processing as a multidistrict litigation.

If you, or someone you love, suffered injury from Essure birth control,  an attorney can help discuss the details and see if you have a potential case.

The Essure Lawsuit is Case No. 2:16-cv-01921-JLS in the U.S. District Court for the Eastern District of Pennsylvania.

In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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Join a Free Essure Class Action Lawsuit Investigation

If you or a loved one were injured by Essure birth control complications, you may have a legal claim. See if you qualify to pursue compensation and join a free Essure class action lawsuit investigation by submitting your information for a free case evaluation.

An attorney will contact you if you qualify to discuss the details of your potential case.

Please Note: If you want to participate in this investigation, it is imperative that you reply to the law firm if they call or email you. Failing to do so may result in you not getting signed up as a client, if you qualify, or getting you dropped as a client.

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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.